Chemical characterisation of medical devices: from theory to real applications

Chemical characterisation is becoming increasingly more important in the world of medical devices at various stages throughout a product’s life cycle. The extension and depth of biological investigations are normally directly linked to the level of risk associated with the device, and this is true for chemical characterisation as well. Innovative devices are becoming more complex, and it is therefore imperative that the manufacturer has an extensive knowledge of the device.

At the initial phase of a new device development process, information gained by performing chemical characterisation provides the manufacturer with valuable knowledge to progress towards the final prototype.

Once the device design is completed and it is time for the crucial safety assessment phase, the data obtained from chemical characterisation provides important information to be evaluated together with toxicological data to fulfill international regulations. This characterisation takes the form of an extractable study, whose data is critical to determining device safety for patients. The extractable study data is evaluated by following the approach dictated in the ISO-10993-17:2002 standard (“Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances”).

Chemical characterisation can prove to be very useful when it comes to change management. Complex devices are often impacted by changes, from production process to cleaning procedures, from materials suppliers to the sterilisation phase. In many cases a thorough chemical characterisation may help in decreasing the amount of biocompatibility testing to be performed. For example, if the comparison of extractable profiles between an “old” and “new” device shows no relevant differences or are toxicologically equivalent (bridging concept), then you may be able to limit the requirements to the execution of a reduced set of biocompatibility tests.

This area is evolving quickly, and the availability of extended and comprehensive guidelines is limited. Eurofins experts are ready to support medical device companies in identifying the proper solutions and best testing options for their medical devices. Please contact medical-device@eurofins.com for any query or need you may have.